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Latest From Amgen, Inc.
Keeping Track: Return & Renewal At US FDA
Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.
Deal Watch: Merck KGAA Teams With AI Biotechs On Drug Discovery Efforts
Plus deals involving Debiopharm/SunRock, RefleXion/3B Pharmaceuticals, Pharmanovia/Sanofi and more.
Travere Hopes For FDA Full Approval Despite Filspari Trial Endpoint Miss
The company said the “totality of data” from the confirmatory PROTECT trial in IgA nephropathy showed the drug slowed decline in kidney function.
A Year And A Half After Giving Up On TAK-721, Takeda Seeks Approval In EoE
The US FDA rejected TAK-721 for eosinophilic esophagitis (EoE) in 2021, requiring another study, and Takeda ended development in 2022, but in a newly accepted NDA it is seeking a short-term treatment indication.
Company Information
- Industry
- Biotechnology
- Pharmaceuticals
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Pharmaceuticals
- Specialty Pharmaceuticals
- Other Names / Subsidiaries
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- Abgenix
- Amgen Astellas BioPharma K.K.
- Amgen K.K.
- Avidia
- BioVex Group
- Catherex, Inc.
- ChemoCentryx, Inc.
- deCODE Genetics
- Dezima Pharma B.V.
- Five Prime Therapeutics, Inc.
- Ilypsa
- Immunex Corporation
- KAI Pharmaceuticals
- Kirin-Amgen Inc.
- Laboratorio Quimico Farmaceutico Bergamo Ltd
- Micromet, Inc. (CancerVax Corporation)
- Nuevolution AB
- Nuevolution A/S
- Onyx Pharmaceuticals, Inc. (Proteolix, Inc.)
- Saga Investments LLC
- Tularik
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